Kornimate/medical-research-clean huggingface dataset:
a study to evaluate astegolimab in participants with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (copd) who are former or current smokers and have a history of frequent exacerbations.


Eligibility criteria:
inclusion criteria * documented copd diagnosis for ≥ 12 months * history of frequent exacerbations, defined as having had 2 or more moderate or severe copd exacerbations within 12 months prior to screening * post-bronchodilator fev1 ≥ 20% and \< 80% of predicted at screening * post-bronchodilator fev1/fvc \< 0.70 at screening * modified medical research council (dyspnea scale) (mmrc) score ≥ 2 * current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years * on optimized copd maintenance therapy as defined below for ≥ 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: inhaled corticosteroid (ics) plus long-acting beta-agonist (laba), long-acting muscarinic antagonist (lama) plus laba, ics plus lama plus laba * chest x-ray or computed tomography (ct) scan within 6 months prior to screening or chest x-ray during the screening period that confirms the absence of clinically significant lung disease besides copd exclusion criteria * current documented diagnosis of asthma * history of clinically significant pulmonary disease other than copd * diagnosis of 1-antitrypsin deficiency * history of long-term treatment with oxygen at \> 4.0 liters/minute * lung volume reduction surgery or procedure within 12 months prior to screening * individuals participating in, or scheduled for, an intensive copd rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible) * history of lung transplant * any infection that resulted in hospital admission for ≥ 24 hours and/or treatment with oral, iv, or im antibiotics within 4 weeks prior to or during screening * upper or lower respiratory tract infection within 4 weeks prior to or during screening * treatment with oral, iv, or im corticosteroids within 4 weeks prior to initiation of study drug * initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months prior to screening * unstable cardiac disease, myocardial infarction, or new york heart association class iii or iv heart failure within 12 months prior to screening
susceptibility to high altitude pulmonary edema in subjects with increased hypoxic pulmonary vasoconstriction

Conditions: High Altitude Pulmonary Edema

Summary: it has been shown, that subjects susceptible to high altitude pulmonary edema (hape)are characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia. this abnormal rise of pulmonary artery pressure has also been observed in about 10 % of otherwise healthy subjects without prior altitude exposure. the aim of the study is to investigate the susceptibility to hape in unacclimatized subjects with abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia after rapid ascent to high altitude (4559 m).


Eligibility criteria:
inclusion criteria: * abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia * ability to climb margherita hut exclusion criteria: * birth at or above 1500 m altitude * any cardiovascular or pulmonary disease * infection disease * intake of drugs, in particular acetazolamide, nifedipine, corticosteroids or pde-5-inhibitors. * pregnancy

Keywords: high altitude pulmonary edema hypoxic pulmonary vasoconstriction right ventricular function hypoxia
a phase 3 efficacy study of pilocarpine hcl ophthalmic solution (agn-190584) in participants with presbyopia

Conditions: Presbyopia

Summary: this clinical study will evaluate pilocarpine hydrogen chloride (hcl) ophthalmic solution (agn-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.


Eligibility criteria:
inclusion criteria subjective complaints of poor near vision that impact activities of daily living exclusion criteria uncontrolled systemic disease any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of agn-190584. history of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. however, participants with history of photorefractive keratectomy (prk) or laser-assisted in situ keratomileusis (lasik) with corrected distance visual acuity (cdva) meeting inclusion criteria will be allowed to enroll. known allergy or sensitivity to the study intervention or its components or other cholinergic agonist medications concurrent use of any topical ophthalmic medications, including artificial tears, other than the study intervention during the course of the study concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study participation in a blood or plasma donation program within 30 days prior to study intervention administration severe dry eye disease (defined as total corneal staining ≥ grade 3 on the 5-point oxford scale and an ocular surface disease index (osdi) score of \> 33) at the screening visit corneal abnormalities (including keratoconus, corneal scar, fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity narrow iridocorneal angles (shaffer grade ≤ 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy history of iris trauma, adie's tonic pupil, abnormal pupil shape in either eye, or anisocoria \> 1 mm between pupils under mesopic conditions at the screening visit lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy diagnosis of any type of glaucoma or ocular hypertension bifocal or multifocal spectacles or contact lenses for habitual correction. participants willing to wear study-provided monofocal correction (either spectacles or contact lenses) during the study can be enrolled abnormal and clinically significant results according to the investigator or designee, on physical/ophthalmic examination or medical history females who are pregnant, nursing, or planning a pregnancy during the study
a single dose pharmacokinetics (pk) study of gsk2434735 in healthy male volunteers

Conditions: Asthma

Summary: an exploratory first time in human (ftih) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of gsk2434735 administered as a single low dose in healthy male subjects

interleukin-13 (il-13) and il-4 are mediators in the pathogenesis of established asthmatic disease. gsk2434735 is a bispecific antibody to il-13 and il-4. the purpose of this open label, sequential cohort, exploratory first time in human (ftih) study is to evaluate the pharmacokinetics (pk) profile of gsk2434735 after a single low intravenous or subcutaneous dose in healthy male volunteers, and to assess if the pharmacokinetics (pk) parameters can be scaled from monkey to man. in addition, the safety and tolerability will be monitored and the study will assess if antibodies are generated to gsk2434735.

Eligibility criteria:
inclusion criteria: * healthy male volunteers between 18 and 65 years of age * negative for pre-existing antibodies to gsk2434735. * body weight greater than and equal to 50 kg * bmi 19 - 29.9 kg/m2. * lifelong non-smokers or ex-smokers of greater than 6 months exclusion criteria: * clinically significant abnormalities. * current or past history of significant cardiac, respiratory, metabolic, renal, hepatic, neurological or gastrointestinal conditions. * current evidence or recent history of an infective illness. * vaccination within 3 weeks of screening * history of severe allergic reactions, angio-oedema, anaphylaxis or immunodeficiency

Keywords: immunogenicity gsk2434735 pharmacokinetics (pk) pk biospecific antibody
serologic testing of household contacts of confirmed cases of covid-19

Conditions: Coronavirus Infection

Summary: sars-cov-2 has now crossed the 1 million number of cases and tens of thousands of deaths. it´s r0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. serologic evidence of infection has not been analyzed.

transverse, observational and descriptive study involving household contacts of documented patients with covid-19 infection: contacts will be invited to participate and a blood sample will be drowned: igm and igg qualitative and quantitative measurements will be performed. demographic data regarding age, comorbidities, calculated time spent before and after the patients diagnosis, isolation practices etc.

Eligibility criteria:
inclusion criteria: 1. persons over 1 years of age. 2. .meet covid-19 confirmed case intradomestic contact definition: 1. living in the same home as the patient with sars-cov-2 pcr test detected (nasopharyngeal and/or oropharyngeal swab) performed in the acute respiratory infection diagnostic unit. 2. living in the same home as the patient with a pcr test for sars-cov-2 indeterminate (nasopharyngeal and/or oropharyngeal swab) performed in the acute respiratory infection diagnostic unit and that the initial patient has positive igm/igg serology for sars-cov-2. 3. .informed consent. exclusion criteria: 1. .have fever, cough, pharyngeal pain or clinically have symptoms compatible with covid-19 at the time of recruitment. 2. .autoimmune disease, cancer, neutropenia. 3. .under 1 years of age. 4. .patients who, in the investigator's opinion, should be excluded from the research protocol.

Keywords: covid-19 igm/igg antibodies intradomestic contacts igm/igg serological tests
evaluation of exhaled breath condensate in the diagnosis of invasive pulmonary aspergillosis

Conditions: Invasive Pulmonary Aspergillosis

Summary: the purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.

invasive pulmonary aspergillosis (ipa) is a life-threatening infection in immunocompromised patients. the poor prognosis of the disease is partly attributed to difficulties encountered with the diagnosis of this infection. invasive sampling procedures are often precluded in these patients. in addition, conventional diagnostic techniques lack sensitivity. recently there has been increasing interest in the investigation of the lungs by noninvasive means including measurement of biomarkers in exhaled breath (e.g. no) and those found in the cooled and condensed exhalate,termed ebc. it has been demonstrated that a measurable fraction of the ebc in healthy subjects is derived from aerosolized airway lining fluid. the presence of biomarkers for ipa will be investigated in ebc of patients with ipa, compared to controls.

Eligibility criteria:
inclusion criteria: * hospitalisation in the hematology or intensive care department * age \> 16 years * informed consent * proven or probable ipa (eortc/ msg criteria) * galactomannan positivity in bal or serum exclusion criteria: * age \< 16 years

Keywords: invasive pulmonary aspergillosis exhaled breath condensate
pharmacokinetics of ertapenem in continuous venovenous hemodialysis

Conditions: Acute Kidney Failure

Summary: critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. ertapenem is an antibiotic often used in these patients. continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. this study will determine how much ertapenem is removed by continuous hemodialysis.

subjects receiving cvvhd will receive a one gram dose of ertapenem. serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by cvvhd and kidneys. a pharmacokinetic evaluation will be made to determine what is the most appropriate dose for this drug in patients receiving cvvhd to achieve pharmacokinetic and pharmacodynamic goals.

Eligibility criteria:
inclusion criteria: * hospitalized in icu * receiving continuous hemodialysis * prescribed ertapenem * informed consent granted exclusion criteria: * \< 18 years of age * allergy to ertapenem or other carbapenem antibiotic * severe, life-threatening reaction to penicillin or cephalosporins * patients experiencing or with history of cns disorders (eg: seizure, stroke) * patients experiencing cns infection * inability to complete 24 hours of cvvhd * concurrent use of other extracorporeal therapies such as extracorporeal membrane oxygenation, plasmapheresis or intermittent hemodialysis * inability to obtain informed consent * pregnant and/or breastfeeding women

Keywords: ertapenem continuous hemodialysis pharmacokinetics
effects of neural glides versus proprioceptive neuromuscular facilitation in cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: this project was a quasi-experimental trial. conducted to compare the effects of neural glides versus proprioceptive neuromuscular facilitation in terms of joint position sense and pain in cervical radiculopathy . so that we can have best treatment option for patients with cervical radiculopathy

non probability convenient sampling was done. patients following eligibility criteria from madina teaching hospital fsd and kadijatulkubra hospital chiniot. non probability convenient sampling was done. sample size was calculated with g power. 28 participants were randomly allocated in two groups equally via convenient sampling method. baseline assessment was done initially. group a was given neural glides and group b was given pnf along with conventional physiotherapy treatment (hot pack and traction). duration of research was almost 6 months. intervention was applied for 4 weeks, 3 sessions per week. pre and post treatment readings were taken in 1st and 4th week session assessment was done via numeric pain rating scale; ndi, cva and jpe as subjective measurements. all participants were provided written informed consent prior to commencement of the procedures. they were free to quit the treatment at any stage of research. data was analyzed by using spss version 23.

Eligibility criteria:
inclusion criteria: * patients with unilateral upper extremity pain, parenthesis, or numbness. * neck disability index (ndi) score of 10/50 points or greater. * numeric pain rating scale scoring (moderate pain). * craniovertebral angle measured less than 49 with forward head posture. * positive distraction test, upper limb tension test, spurling test. exclusion criteria: * any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis etc. * central nervous system involvement. * history of whiplash injury within the previous 6weeks. * prior surgery to the cervical or thoracic spine from 6 months ago.
the effect of diuretics on mineral and bone disorder in chronic kidney disease patients

Conditions: Secondary Hyperparathyroidism; Chronic Kidney Disease

Summary: chronic kidney disease (ckd) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. one of the major complications of ckd is mineral and bone metabolism disorder (ckd-mbd), which include changes in the levels of calcium, phosphorus, vitamin d deficiency, increased circulating levels of fibroblast growth factor (fgf-23) and parathyroid hormone (pth). these alterations are responsible for fractures, cardiovascular disease and mortality among patients with ckd. according to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of pth. although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. only one study, a cohort study in a population of ckd, showed that furosemide was directly related to increased calciuria and pth levels and the use of thiazide, in turn, showed completely opposite effect. however, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. it is possible that calciuria is not a so simple explanation that justifies the pth levels changes, as no correlation was seen between calciuria and pth levels. better understanding of the exact relationship between the use of diuretics and the impact on ckd-mbd may be an alternative intervention, easily accessible and relatively inexpensive. the purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.

this is a prospective randomized study to test the effects of thiazide and furosemide in bone parameters, which will be assessed by peripheral micro-tomography at baseline and 12 months later. the role of calciuria in these possible changes will be tested.

Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate (calculated by ckd-epi) between 30 and 60 ml/min exclusion criteria: * diabetes; * chronic use of: steroid, bisphosphonates and calcium carbonate

Keywords: diuretics furosemide hydrochlorothiazide ckd-mbd hrpqct parathyroid hormone
sharklet catheter study

Conditions: Urinary Catheter; Urinary Tract Infections

Summary: the aim of this study is to determine if the sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

the aim of this study is to determine if the sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

Eligibility criteria:
inclusion criteria: * patient requires a chronic indwelling foley catheter for at least 14 days. catheters will not remain indwelling greater than 30 days at a time * patient is more than 19 years of age * patient is able to give informed consent * patient is able to attend follow-up sessions exclusion criteria: * patient is less than 19 years of age * patient is pregnant * patient with a known allergy to silicone * patient has urinary tract anatomic abnormality that would prevent placement of a standard foley catheter * patient unable to accommodate the catheter * patient has an active urinary tract infection (uti) or other diagnosed infection that is untreated. once the infection has been treated, the patient is eligible for study. * patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period * patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage) * patient is unable to feel and/or communicate their symptoms * informed consent is unable to be obtained * patient is unable or unwilling to comply with the study follow-up schedule * patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis * any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study

Keywords: infection urinary catheter sharklet
the prevalence of psychological and medical comorbidities among children suffering from autistic spectrum disorder and the differences between ethnic groups in israel

Conditions: Autism

Summary: it is known that several psychological and medical comorbidities are frequently found among children suffering from autistic spectrum disorders. our aim is to investigate which comorbidities are most common among those children and whether there are differences among the different ethnic groups found in israel.


Eligibility criteria:
inclusion criteria: * diagnosed with autism exclusion criteria:
interest of the balance of pro-coagulating and profibrinolytis activities of the microparticles (mp) in the prognosis of septic shock

Conditions: the Coagulolytic Balance; the Mortality Rate; the Performance Used to Evaluate the Principal Objective Are Technical Performances, Sensibility and Specificity of the Tests

Summary: septic shock is a clinical syndrome occurring in 10 to 20% of patients admitted in icv. mortality associated to septic shock varies from 30 to 50%. it follows a systemic response of the organism to a severe infection, associated with a circulatory failure marker by an arterial hypotension and a vascular hyperactivity to vasoconstrictor agents. the mechanisms involved on one hand an activation of white blood cells inflammatory system and the vascular inflammatory system; and on the other hand on imbalance in hemostatis characterized by an activation of the coagulation and an inappropriate fibrinolysis leading to a disruption of microcirculation in the context of a disseminated intravascular coagulation (divc). this inflammatory and thrombotic cellular activation is strongly associated with the phenomenon of vesiculation; leading to the production of cellular microparticles (mp) by blood cells and vascular cells. mp are membranous vesicles, resulting in the reassortment of membrane phospholides in response to an activation of cellular apoptosis. they have been initially described as new actors of hemostatis. indeed, the expression of phospholipid serine and tissular factor (tf) confer them a procoagulating activity, which increases in patients undergoing septic shock. the finding of a fibriniolytic activity of the cellular mp suggests the existence of compensating mechanisms with a procoagulating activity. this confers to mp a key-role in the control of the coagulolytic balance. our recent researches suggest that endothelial and white blood cells mp produce in vivo plasmin. they carry into the main circulation a fibrinolytic activity which is partially beyond the physiological inhibitors activity (pai-1, x 2 antiplasmin). preliminary findings show that this ability of plasmin generation is important in patients affected with septic shock. our hypothesis is that an increase in plasmin generation by mp compensates the risk of occurrence of microthrombosis, modulating therefore the vital prognosis of patients with septic shock. the coagulolytic balance of mp, which is resulting of their own procoagulating and fibrinolytic activities could claim the status of new pronostic marker relevant in patients with septic shock.


Eligibility criteria:
inclusion criteria: * patient with septic shock exclusion criteria: * age under 18 yo * pregnant woman * septic shock since more than 24 hours * patient hospitalized for cardiac arrest * immunocompromised patients * patient in whom the stop of active therapeutic is discuss * patient treated with an anti-coagulant at therapeutic dose